Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

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Detailed Description

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This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Crohn's Disease (CD)

Participants with Crohn's Disease treated with adalimumab (HUMIRA®) in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.